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Improving Veteran Access to Integrated Management of Back Pain (AIM-BACK)

Primary Purpose

Low Back Pain, Veterans Family

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain modulation with physical pain treatment
Telephone delivered self-management counseling for increasing physical activity
Telephone delivered behavioral treatment for participants with high risk for continued disability
Patient preference treatment protocol
Nonpharmacological guideline adherent treatment protocol
Facilitated referrals to existing VA or non-VA pain management resources
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring clinical pathway, veterans, low back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Clinic eligibility:

  • Volunteer and return signed clinic participation agreement
  • Availability of clinical personnel willing to deliver the treatment interventions (in either arm).
  • Staff and location need to be distinct from other enrolled clinics.
  • Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain.

Participant Survey Eligibility Criteria:

Inclusion Criteria:

  1. Age >= 18
  2. Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic
  3. Provider determines LBP is appropriate for conservative management
  4. Referred to integrated ICP pathway or CCP pathway by participating clinic provider

Exclusion Criteria:

  1. Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults)
  2. No documented phone number in the electronic health record.

Sites / Locations

  • Durham VARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Integrated Care Pathway

Coordinated Care Management Pathway

Arm Description

The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.

The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.

Outcomes

Primary Outcome Measures

Change in Pain Interference Measure
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome.
Change in Physical Function Measure
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with one representing a better outcome

Secondary Outcome Measures

Change in Sleep Disturbance
The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome
Change in Patient reported Outcomes--PROMIS Sleep Disturbance
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome
Change in Opioid Use--Chronic User
opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months
Change in Opioid Use--Morphine Dose
opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months
Change in Patient Reported Outcomes--PROMIS Pain Interference
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with one representing a better outcome
Change in Patient Reported Outcomes--PROMIS Physical Function
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with one representing a better outcome.

Full Information

First Posted
May 27, 2020
Last Updated
May 2, 2023
Sponsor
Duke University
Collaborators
Durham VA Medical Center, University of North Carolina, Chapel Hill, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04411420
Brief Title
Improving Veteran Access to Integrated Management of Back Pain
Acronym
AIM-BACK
Official Title
Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Durham VA Medical Center, University of North Carolina, Chapel Hill, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Veterans Family
Keywords
clinical pathway, veterans, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a 4-year cluster randomized pragmatic trial comparing the effectiveness of a sequenced, multi-modal integrated care pathway for lower back pain (LBP) to a care management by pain navigator program for LBP. The study target population is veterans seeking services for lower back pain in participating VA clinics. We plan to enroll 16 VA clinics randomized in a 1:1 Ratio using a covariate constrained randomization.
Masking
Outcomes Assessor
Masking Description
The only blinded members of the project include the VA research and Duke Clinical Research Institute (DCRI) research staff members administering the consent and follow up survey data collection processes. All other team members will be unblinded due to the pragmatic design.
Allocation
Randomized
Enrollment
1680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated Care Pathway
Arm Type
Active Comparator
Arm Description
The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.
Arm Title
Coordinated Care Management Pathway
Arm Type
Active Comparator
Arm Description
The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Intervention Type
Behavioral
Intervention Name(s)
Pain modulation with physical pain treatment
Intervention Description
Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
Intervention Type
Behavioral
Intervention Name(s)
Telephone delivered self-management counseling for increasing physical activity
Intervention Description
Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
Intervention Type
Behavioral
Intervention Name(s)
Telephone delivered behavioral treatment for participants with high risk for continued disability
Intervention Description
Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.
Intervention Type
Behavioral
Intervention Name(s)
Patient preference treatment protocol
Intervention Description
the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
Intervention Type
Behavioral
Intervention Name(s)
Nonpharmacological guideline adherent treatment protocol
Intervention Description
the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
Intervention Type
Behavioral
Intervention Name(s)
Facilitated referrals to existing VA or non-VA pain management resources
Intervention Description
the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.
Primary Outcome Measure Information:
Title
Change in Pain Interference Measure
Description
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome.
Time Frame
Baseline, three months post baseline
Title
Change in Physical Function Measure
Description
The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with one representing a better outcome
Time Frame
Baseline, three months post baseline
Secondary Outcome Measure Information:
Title
Change in Sleep Disturbance
Description
The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome
Time Frame
Baseline, three months post baseline
Title
Change in Patient reported Outcomes--PROMIS Sleep Disturbance
Description
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome
Time Frame
Baseline, three, six, nine and twelve months
Title
Change in Opioid Use--Chronic User
Description
opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months
Time Frame
Baseline, twelve months post baseline
Title
Change in Opioid Use--Morphine Dose
Description
opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months
Time Frame
Baseline, twelve months post baseline
Title
Change in Patient Reported Outcomes--PROMIS Pain Interference
Description
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with one representing a better outcome
Time Frame
Baseline, three, six, nine and twelve months
Title
Change in Patient Reported Outcomes--PROMIS Physical Function
Description
The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with one representing a better outcome.
Time Frame
Baseline, three, six, nine and twelve months
Other Pre-specified Outcome Measures:
Title
Change in Patient Reported Outcomes--Catastrophizing
Description
Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, nine, and twelve months post baseline and will evaluate catastrophizing with several agree / disagree questions.
Time Frame
Baseline, three, six, nine and twelve months
Title
Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)
Description
The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure alcohol use. The AUDIT-C form asks the participant to rate a series of alcohol use questions on a scale of 0-4 with zero representing a better outcome
Time Frame
Baseline, three, six, nine and twelve months
Title
Change in Patient Reported Outcomes--Pain intensity, Enjoyment of life, general activity (PEG) screening tool
Description
The PEG screening tool scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure pain intensity. The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome
Time Frame
Baseline, three, six, nine and twelve months
Title
Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)
Description
Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, nine, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome.
Time Frame
Baseline, three, six, nine and twelve months
Title
Change in Patient Reported Outcomes--Depressed Mood
Description
The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, nine and twelve months post baseline to measure depressed mood. The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week.
Time Frame
Baseline, three, six, nine and twelve months
Title
Change in Patient Reported Outcomes--Quality of Life
Description
The EUROQUOL five item quality of life questionnaire will be administered by interviewers at baseline, three, six, nine and twelve months post baseline to measure quality of life. The EUROQUOL asks the participant a series of questions related to quality of life on a scale of 0-5.
Time Frame
Baseline, three, six, nine and twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Clinic eligibility: Volunteer and return signed clinic participation agreement Availability of clinical personnel willing to deliver the treatment interventions (in either arm). Staff and location need to be distinct from other enrolled clinics. Clinics can have a variable number of providers, but together meet criteria for range of monthly visits for low back pain. Participant Survey Eligibility Criteria: Inclusion Criteria: Age >= 18 Seeking care for LBP with or without radiating symptoms from a participating VA primary care clinic Provider determines LBP is appropriate for conservative management Referred to integrated ICP pathway or CCP pathway by participating clinic provider Exclusion Criteria: Receiving or referred for hospice/ palliative care (defined by encounter codes and CPRS consults) No documented phone number in the electronic health record.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leo Brothers, MPH
Phone
919-668-8322
Email
joseph.l.brothers@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Stanwyck
Email
catherine.stanwyck@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan N Hastings, MD
Organizational Affiliation
Duke University / Durham VA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Z George, PT, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study data sets will be shared a timely manner with privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website. To enable broad resource sharing, the study statistician will create de-identified, publication-specific datasets including all variables presented in the publication. The PIs hold responsibility for ensuring that the individuals cannot be re-identified. No data or code that could lead to re-identification of individuals will be released. The analytical datasets and statistical code used will be retained in accordance with VA record retention policy. Study manuals and clinical tools will be shared with the NIH PMC3 Collaboratory and VA health care system facilities. If successful outcomes justify broader dissemination, we will seek to do so by placing relevant materials into the public domain.
IPD Sharing Time Frame
The data and other resources referenced will be available one year after the date of publication for the primary analyses, which is in alignment with the VA Office of Research and Development.
IPD Sharing Access Criteria
We plan on using a de-identified dataset is not subject to HIPAA's minimum necessary standards and would not require a data use agreement. Typically datasets will be provided in SAS transport files using CDISC standards via a website. Requesters will have to enter a valid email, phone number and address to request data. The data provided will be made available under certain requirements and approved on a case by case basis. Requirements include: data will be used for research purposes and not to identify subjects data must be secured using appropriate computer technology data must be destroyed or returned after any analysis are complete authors of any manuscript resulting from this data must acknowledge the source of the data analyses for the purpose of presentations, abstracts, and/or publications must be coordinated through the Publications Committee, to avoid overlap coauthors must be given a chance for review and approval of a draft manuscript prior to submission

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Improving Veteran Access to Integrated Management of Back Pain

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